cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia

Обзор

Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care during the same procedure.

Подробное описание

The OPTION-A Study is an observational, prospective, single-arm, multi-center non-mandated post-market study. Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and according to hospitals' standard of care. The objective(s) of the OPTION-A Study is to evaluate safety and effectiveness of catheter ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent implant of Left Atrial Appendage closure (LAAC) with the WATCHMAN™ LAA Closure device in a concomitant procedure.

Вмешательства

• Устройство FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
  The FARAPULSE™ PFA System consists of the FARAWAVE™ Pulsed Field Ablation Catheter, the FARASTAR™ Pulsed Field Ablation Generator, and the FARADRIVE™ Steerable Sheath. The WATCHMAN LAA Closure Technology consists of the WATCHMAN Access System (which consists of the Access Sheath and Dilator and the WATCHMAN Delivery System (which consists of the delivery catheter and the pre-loaded closure device). The WATCHMAN Access System and WATCHMAN Delivery System permit device placement in the LAA via fe

Первичные конечные точки

• Periprocedural or procedure-related Composite Serious Adverse Events will be assessed [Срок оценки: 30 days post index procedure]
• Acute Treatment Success will be assessed [Срок оценки: between index procedure and 30 days post index procedure]

Вторичные конечные точки (1)

• Device or procedure-related Composite Serious Adverse Events (CSAEs) assessed [Срок оценки: 1 year post index procedure]

Критерии участия

Критерии включения

• Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN for LAAC, per physician medical judgement and as per hospitals' standard of care.
• Subjects who are willing and able to provide informed consent.
• Subjects who are willing and able to participate in all testing associated with this clinical study at an approved clinical investigational center.
• Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.

Критерии исключения

• Subjects who underwent prior AF ablation procedure.
• Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.
• Already surgically closed or otherwise excluded LAA.
• The LAA anatomy does not accommodate a Closure Device.
• Known or suspected atrial myxoma.
• Presence of intracardiac thrombus.
• Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an ASD/PFO device.
• Subjects with a presence of a mechanical valve prosthesis in any position.
• Subjects with a myocardial infarction within 30 days prior to enrollment.
• Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
• Any planned electrical cardioversion within 30 days following LAAC device implant.
• Subjects with a known inability to obtain vascular access.
• Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy), active conditions (e.g. infection, bleeding disorder, unstable angina) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present\*.
• Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina) are present.
• Subjects with any contraindications to short term use of anticoagulation therapy, or aspirin for conditions different from atrial fibrillation.
• Subjects who are pregnant or planning to be pregnant.
• Subjects with a life expectancy of ≤ 1 year per investigator's opinion.
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 15 центров

• The First Affiliated Hospital of Soochow University — Сучжоу
• Beijing Anzhen Hospital of the Capital University of Medical Sciences — Пекин
• Xuanwu Hospital Capital Medical University — Пекин
• Huaxi Hospital of Sichuan University — Чэнду
• The First Affiliated Hospital of Chengdu Medical College — Чэнду
• Guangdong Nanfang Hospital — Гуанчжоу
• The Third Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The Affiliated Hospital of Guizhou Medical University — Guiyang
• … и ещё 7 центров

Япония · 11 центров

• Shonan Kamakura General Hospital — Kamakura-shi
• Sendai Kousei Hospital — Sendai
• Kurashiki Central Hospital — Kurashiki-shi
• Saitama Red Cross Hospital — Saitama
• Sakakibara Heart Institute, Sakakibara Heart Foundation — Fuchu-shi
• Kokura Memorial Hospital — Fukuoka-ken
• Yokosuka Kyosai Hospital — Kanagawa
• Kawasaki Saiwai Hospital — Kawasaki
• … и ещё 3 центра

Гонконг · 4 центра

• Prince of Wales Hospital — Гонконг
• Princess Margaret Hospital — Гонконг
• Queen Mary Hospital — Гонконг
• Queen Elizabeth Hospital — Kowloon

Тайвань · 4 центра

• China Medical University Hospital — Taichung
• Taichung Veterans General Hospital — Taichung
• National Taiwan University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Малайзия · 2 центра

• Institute Jantung Negara — Kuala Lumpur
• Pusat Jantung Sarawak — Kuching

Сингапур · 1 центр

• Asian Heart and Vascular Centre — Singapore

Идентификаторы

NCT: NCT06686485 · PF316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗